Seasonal Allergic RhinitisPhase 4GEYSERNCT00561717
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis
A Phase 4 study of Seasonal Allergic Rhinitis, run by Bayer at 1 site in Canada.
Trial summary
Finding out how fast azelastine nasal spray works in subjects with hay fever. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
- Positive response to skin prick test to ragweed allergen at screening;
- Be willing to participate in the trial.
Who cannot join
- History of hypersensitivity to azelastine;
- Females who are pregnant or lactating;
- Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
- Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
- Known non-responsiveness to antihistamines;
- Alcoholism or drug abuse within 2 yrs. of screening;
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- Current or regular use within 6 months of any type of tobacco product;
- Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
- History of a positive test to HIV, TB, hepatitis B or C.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis
Finding out how fast azelastine nasal spray works in subjects with hay fever.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Azelastine and placebo, Loratadine and Placebo, Cetirizine and Placebo, Placebo and Placebo (spray and Tablet)
- Keywords
- Seasonal Allergic Rhinitis, Ragweed, Pollen, Allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelastine and placeboDrug
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Loratadine and PlaceboDrug
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Cetirizine and PlaceboDrug
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
Placebo and Placebo (spray and Tablet)Drug
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Azelastine and placebo |
| Arm 2 | Active comparator | Not described Receives: Drug: Loratadine and Placebo |
| Arm 3 | Active comparator | Not described Receives: Drug: Cetirizine and Placebo |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo and Placebo (spray and Tablet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline
Measured: Up to 6 hours
Secondary outcomes (1)
Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
Measured: Effect over 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kingston Health Sciences Centre
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561717
- Sponsor's protocol ID
- 12962
- Other IDs
- 9427-B2171-22C (CR Number)
- Acronym
- GEYSER
- Status last verified
- May 2013
- First submitted
- 20 Nov 2007
- Last updated
- 7 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.
PubMed 29371864
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00561717
- Acronym / sponsor ID
- GEYSER / 12962
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Seasonal Allergic Rhinitis, Ragweed, Pollen, Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Kingston Health Sciences Centre
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Finding out how fast azelastine nasal spray works in subjects with hay fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Azelastine and placebo |
| Arm 2 | Active comparator | Drug: Loratadine and Placebo |
| Arm 3 | Active comparator | Drug: Cetirizine and Placebo |
| Arm 4 | Placebo comparator | Drug: Placebo and Placebo (spray and Tablet) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
- Positive response to skin prick test to ragweed allergen at screening;
- Be willing to participate in the trial.
Key exclusion criteria (9 listed)
- History of hypersensitivity to azelastine;
- Females who are pregnant or lactating;
- Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
- Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
- Known non-responsiveness to antihistamines;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azelastine and placeboOne Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms. | Drug | Arm 1 |
| Loratadine and PlaceboOne placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms. | Drug | Arm 2 |
| Cetirizine and PlaceboOne placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms. | Drug | Arm 3 |
| Placebo and Placebo (spray and Tablet)One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms. | Drug | Arm 4 |
Primary outcome
Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline
Time frame: Up to 6 hours
1 secondary outcome
Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
Time frame: Effect over 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Derived from this study: PubMed 29371864Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Seasonal Allergic Rhinitis, run by Bayer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline (time frame: Up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00561717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013; AzTrials last refreshed its copy on 31 Oct 2026.